This invention relates to control of medication use and in particular to a device and method to aid in patient compliance with a prescribed dosage of medication.
The problem of a patient adhering to a dosage scheme for medicine prescribed by a physician is acute. Medicine is always prescribed with a particular dosage taken at certain intervals taken during the day and sometimes into the night. The dosage requirements are complicated by varying starting times during the day. While it is desirable that the patient stay on a regular regimen, for example starting the medicine taking at a certain time, it is common for the patient to be a little early or a little late when starting thus changing the regimen from day to day. Further, it is known that persons are prone to forget not only whether the medicine has been taken, but also when the last dose was taken. As a consequence, the patient frequently takes medicine on a more frequent interval than prescribed or on a longer interval such that the effectiveness of the medicine and the continuous level of medication carried through the body system is interrupted. The failure to adhere to the prescribed dosage may result in complications or at the minimum interfere and make less effective the medicine prescribed. The problem of taking medicine at the proper times and in the proper dosages is even more serious with the aged and infirm. Needless to say, a person who is seriously ill has a more difficult time adhering to the prescription and keeping track of the time when the last dose was taken and when the next dose is due. In addition, there is a certain percentage of individuals, regardless of age or infirmity, that are not careful in keeping track of the time when the dose of a medicine was last taken. Further, since taking the dose of medicine is extremely repetitive, it is difficult to remember whether the medicine was actually taken, even if it was only a few hours ago. A further complication of failing to be sure that the last dose was taken or when the next dose is due is the mental strain and worry asociated with the problem. Particularly for aged persons, such concern can weigh heavily on their confidence and emotional well being.
This problem is well known and there have been a number of attempts in the prior art to aid the patient in complying with drug therapy. Such a device is described in U.S. Pat. No. 4,419,016 to BART J. ZOLTAN describing a time keeping device incorporated into a typical container for medicinal products. Specifically, the device is provided either as a separate element or as part of the cap or cover of the medicine container. While it is suggested that the ZOLTAN device need not be integral or part of the medicine container and can be utilized as a reusable item with fresh containers, all of the devices are directed to the closure mechanism and register the time when the closure was last closed. A time keeping device displays the time and day of the week when the container was last opened by the patient and continues to display that same time, even after closing the container to serve as a reminder to the patient when the medicine was last taken. The ZOLTAN time keeping device is also provided with settable alarms to visually or audibly alert the patient as to when the next dose is to be taken. A problem with the ZOLTAN device is the multiplicity of the size of pharmaceutical containers and the various designs and construction of such containers. It is therefore difficult to incorporate the ZOLTAN device with a multiplicity of container closures thus limiting the scope of its use.
Other prior art devices include dispensing containers in which each individual dosage unit is provided in a separate compartment with each compartment identified as to a particular time or numerical sequence. Such containers are described in U.S. Pat. Nos. 4,038,937; 4,158,411; and 4,295,567.
Other devices have relied on calendar indicators and timers which can be set and combined with individual compartments for the dosage unit of the medication to be taken. U.S. Pat. No. 4,911,856 discloses such a device. At the prescribed time, the user rotates the cap to uncover the desired compartment for access to the medication. A date selector and timer which can be set for the period to provide an indication as to the next time to use the medication is included.
U.S. Pat. No. 4,034,757 describes a container with a compliance monitor. This container includes two compartments, one for the medication and the other for the recording circuitry. When the cap is removed and when the container is inverted, the circuitry is activated with the data being stored in addressable memory. The data is read by a clinician.
Another device is described in U.S. Pat. No. 4,223,801 as an automatic periodic drug dispensing system. This system includes a multi-compartment container which is color coded corresponding with dots on the face of a watch to indicate when the medication should be taken. Another device described in the same patent includes a timer integral with the container which signals when the medication should be taken as well as a switching device activated by the user to eliminate the signal and open the compartment to access the medication. Also included is a device which relies on a paging signal from a UHF radio received by crystals in the device to register the particular regimen prescribed for the patient.
All of these devices have the disadvantage of incorporating the medication control with the dispenser. Thus, the supplier of the controlling device must either supply the dispenser or design the controlling device so that it fits a particular dispenser or group of dispensers. None of these devices satisfy the need to alert the patient to take medicine from virtually any size or shape container or attain the objects described hereinbelow.